Do not take Memantine easypharm
if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Memantine easypharm
Take special care with Memantine easypharm:
- if you have a history of epileptic seizures
- if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine easypharm reassessed by your doctor on a regular basis.
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the Memantine easypharm doses accordingly.
The use of medicinal products called amantadine (for the treatment of Parkinson´s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA- antagonists at the same time should be avoided.
You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
| issue date: 25-09-13 | version: M1.3.1_03.MMN.hcl.tab.101.03.NL.2719.02 | approved: CHo |
Common Technical Document
Memantine HCl
Film-coated tablets
| Module 1 - Section 3.1 SPC, Labelling | |
| and Package Leaflet | page 3/9 |
Children and adolescents
Memantine easypharm is not recommended for children and adolescents under the age of 18 years.
Other medicines and Memantine easypharm
Memantine easypharm may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
- amantadine, ketamine, dextromethorphan
- dantrolene, baclofen
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
- hydrochlorothiazide (or any combination with hydrochlorothiazide)
- anticholinergics (substances generally used to treat movement disorders or intestinal cramps).
- anticonvulsants (substances used to prevent and relieve seizures)
- barbiturates (substances generally used to induce sleep)
- dopaminergic agonists (substances such as L-dopa, bromocriptine)
- neuroleptics (substances used in the treatment of mental disorders)
- oral anticoagulants
Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the medicines listed above or any other medicines.
If you go into hospital, let your doctor know that you are taking Memantine easypharm.
<Memantime> with food and drink
Food does not influence the effect of Memantine easypharm.
Pregnancy and breast-feeding
The use of Memantine easypharm in pregnant women is not recommended.
Women taking Memantine easypharm should not breast-feed.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
| issue date: 25-09-13 | version: M1.3.1_03.MMN.hcl.tab.101.03.NL.2719.02 | approved: CHo |
Common Technical Document
Memantine HCl
Film-coated tablets
| Module 1 - Section 3.1 SPC, Labelling | |
| and Package Leaflet | page 4/9 |
Driving and using machines
Your doctor will tell you whether your illness allows you to drive and to use machines safely. Moreover, Memantine easypharm may change your reactivity, making driving or operating machinery inappropriate.
Memantine easypharm contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
| 3. | How to take Memantine easypharm | |
| | Always take this medicine exactly as your doctor or pharmacist has told you. |
| | Check with your doctor or pharmacist if you are not sure. | |
| | Dosage | | | |
| | <10 mg> | | | |
| | The recommended dose of Memantine easypharm for adults and elderly |
| | patients is 20 mg once a day. | |
| | In order to reduce the risk of side effects this dose is achieved gradually by |
| | the following daily treatment scheme: | |
| | week 1 | | half a 10 mg tablet | |
| | week 2 | | one 10 mg tablet | |
| | week 3 | | one and a half 10 mg tablet | |
| | week 4 and beyond | two 10 mg tablets once a day | |
| | The recommended dose can also be achieved by using a treatment initiation |
| | pack. | | | |
| | The usual starting dose is half a tablet once a day (1x 5 mg) for the first |
| | week. This is increased to one tablet once a day (1x 10 mg) in the second |
| | week and to 1 and a half tablet once a day in the third week. From the fourth |
| | week on, the usual dose is 2 tablets once a day (1x 20 mg). | |
| | <20 mg> | | | |
| | The recommended dose of Memantine easypharm for adults and elderly |
| | patients is 20 mg once a day. | |
| | In order to reduce the risk of side effects this dose is achieved gradually by |
| | the following daily treatment scheme. For up-titration other tablet strengths |
| | are available. | | | |
| | At the beginning of treatment you will start by using Memantine easypharm 5 |
| | mg film-coated tablets once a day. This dose will be increased weekly by 5 |
| | mg until the recommended (maintenance) dose is reached. The recommended |
| issue date: 25-09-13 | version: M1.3.1_03.MMN.hcl.tab.101.03.NL.2719.02 | approved: CHo |
Common Technical Document
Memantine HCl
Film-coated tablets
| Module 1 - Section 3.1 SPC, Labelling | |
| and Package Leaflet | page 5/9 |
maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week.
Dosage in patients with impaired kidney function
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
<10 mg>
Breaking the tablet
Place the tablet with the round side on a hard surface, the score line should face upwards. Press with the forefinger and thumb of the same hand on either side of the score line and push down until the tablet breaks as shown in the illustration.
<20 mg>
Breaking the tablet
Place the tablet with the round side on a hard surface, the score line should face upwards. Press with the forefinger and thumb of the same hand on either side of the score line and push down until the tablet breaks as shown in the illustration.
Administration
Memantine easypharm should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water. The tablets can
| issue date: 25-09-13 | version: M1.3.1_03.MMN.hcl.tab.101.03.NL.2719.02 | approved: CHo |
Common Technical Document
Memantine HCl
Film-coated tablets
| Module 1 - Section 3.1 SPC, Labelling | |
| and Package Leaflet | page 6/9 |
be taken with or without food.
Duration of treatment
Continue to take Memantine easypharm as long as instructed by your doctor. He will assess your treatment on a regular basis.
If you take more Memantine easypharm than you should
In general, taking too much Memantine easypharm should not result in any harm to you. You may experience increased symptoms as described in section 4, Possible side effects.
If you take a large overdose of Memantine easypharm, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take Memantine easypharm
If you have forgotten to take your dose of Memantine easypharm, wait and take your next dose at the usual time.
Do not take a double dose to make up for the forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
